Uterine atony is a failure of the uterine muscles to contract following delivery, whether by normal vaginal delivery or caesarean section, and represents the most common cause of postpartum hemorrhage (PPH). Currently, there are 130 million deliveries a year, worldwide and 4 million a year in the United States. 33% of the delivers in the U.S. occur via a caesarean section. Currently, approximately 960 maternal deaths occur per year in the United States with 25% of maternal death due to hemorrhage. Presently, treatment for PPH is substantially pharmaceutical in nature, and includes, the administration of oxytocin (Pitocin, Syntocinon), ergot derivatives such as Ergometrine and Methergine, and Carboprost (Hemabate), and various synthetic prostaglandins such as Misoprostol. While pharmacologic treatments for uterine atony do work well in many cases, there are still disadvantages. Patients can have a contraindication to a standard pharmacologic agent. For example, ergot derivatives are contraindicated in hypertensive patients. Other medications are not recommended for patients with asthma. Pitocin has been shown to cause cardiac collapse, hypotension, chest pain and headaches.
More recently, as an adjunct to pharmacologic agents, bladder tamponades such as the Bakri catheter have gained acceptance in clinical settings. Typically, such balloons are expandable by means of a saline injection into the body of the bladder. While a laudable addition to available treatments, efficacy for bladder tamponades of this type is not well established. Accordingly, it would be desirable to provide a non-pharmacological solution that can be used alone or in combination with other pharmacological and non-pharmacological modalities to control uterine atony and thereby control or prevent bleeding after a cesarean section or other procedure.